The present invention relates generally to thermal enclosures, and more particularly to a novel and improved combination thermal storage and/or shipping container and leak-resistant containment bag for maintaining blood specimens and other potentially infectious materials at a given temperature for extended periods.
The procedures for handling and storage of blood, urine and similar specimens collected in a doctor's office or clinic for transfer by a courier to a laboratory for testing vary widely depending on the nature of the specimen, temperature constraints, storage time before they are picked up by the courier, and the storage facilities at the doctor's office and provided by the courier service. For instance, containers of non-critical specimens, which can be stored at room temperature, may be placed directly in a lock box located inside or outside the doctor's office for pick-up. Blood specimens, on the other hand, are usually collected in vials by a technician and placed in a typical household freezer operating in the range of approximately -10.degree. F. to 10.degree. F. If courier pick-up is immediate or the same day before office closing, the frozen or partially frozen specimens are transferred directly to a freezer or dry ice container in the courier's van. However, if pick-up is after office hours, frozen specimens would be transferred to a specially designed insulated lock box located in an area outside the office accessible to the courier. If the lock box is at room or ambient temperature, there is the danger that the specimens will begin to thaw out before the courier arrives.
Extra precautions against leakage are required if the specimens are blood or other potentially infectious biological materials to which exposure can cause serious diseases in humans. If outside contamination of their primary container can occur, the Standards for Bloodborne Pathogens under the Occupational Safety and Health Act (OSHA) require (1) that the material be placed within a secondary container for protection against leakage during handling, processing, storage, transport or shipping, and (2) that the secondary container be properly labeled or color-coded to warn handlers of its contents. In addition, identification documents are usually enclosed with the materials in the secondary container along with instructions as to the tests to be performed.
Heretofore, prior art containers for storage and/or shipping biological specimens, which meet the OSHA standards for potentially infectious materials, have not been available. For instance, the container disclosed in U.S. Pat. No. 3,802,220 is not a leak-resistant container suitable for infectious materials.